Ortho Recalls VITROS Anti-SARS-CoV-2 IgG Control Due to Signal Issues
Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Control and Calibrator lots due to elevated signal/cutoff values and decreased signal.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho Clinical Diagnostics Inc is recalling 691 units of VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control (Product Code 6199921) and eight lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator. The recall was initiated because of elevated sample results signal/cutoff (s/c) values observed when using the Calibrator and decreased signal observed in one lot of the Control.
The affected products were distributed worldwide, including in the United States, Australia, Brazil, Chile, China, Colombia, India, Japan, Singapore, the United Kingdom, and Italy. The specific lot number for the Control is 0110 with an expiration date of 25-NOV-20.
These products are used for monitoring the performance of VITROS Immunodiagnostic and Integrated Systems when determining IgG antibodies to SARS-CoV-2. Users should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determination of IgG antibodies to SARS-CoV-2. Product Code (Unique Identifier)…
- Manufacturer
- Ortho Clinical Diagnostics Inc
- Affected units
- 691
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number/ Exp. Date: 0110 25-NOV-20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ortho Clinical Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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